Retained Products of Conception Clinical Trial
Official title:
MISOPROSTOL FOR THE TREATMENT OF SUSPECTED POSTPARTUM RETAINED PRODUCTS OF CONCEPTION - A RANDOMIZED TRIAL
The goal of this current study is to evaluate the efficacy of treatment of postpartum patients with suspected retained products of conception (RPOC) with Misoprostol in reducing the frequency of postpartum RPOC compared to a control group of patients that will be managed expectantly, in a prospective randomized trial.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Women between the ages of 18 years - 45 years. - Spontaneous vaginal delivery or vacuum extraction, including VBAC cases - Revision of the uterine cavity or manual lysis of the placenta postpartum - Early postpartum hemorrhage - Cases with a history of treated postpartum residua (by curettage or hysteroscopy) - Placental pathology (succenturiate placenta, bilobed placenta) - Pregnancy that started as a multifetal gestation with only one fetus reached advanced pregnancy - Bumm curettage post-delivery - Patients are able to provide written consent Exclusion Criteria: - Patients with no risk factors of RPOC - Cesarean section on index pregnancy - Cases requiring urgent curettage for late postpartum hemorrhage - Inability to consent due to cognitive or language barrier |
Country | Name | City | State |
---|---|---|---|
Israel | Assuta Ashdod University Hospital | Ashdod |
Lead Sponsor | Collaborator |
---|---|
Assuta Ashdod Hospital |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cases of retained products of conception | The primary endpoint will be the number of patients with histopathology-proven retained products of conception at 8-16 weeks postpartum in each group. | 8-16 weeks postpartum | |
Secondary | Need for hysteroscopy due to suspected RPOC | number of hysteroscopies in each group | 8-16 weeks postpartum | |
Secondary | side effects of treatment | any side effects of treatments with Misoprostol | 8-16 weeks postpartum | |
Secondary | Late postpartum hemorrhage | Late postpartum hemorrhage during the followup | 6 weeks postpartum | |
Secondary | Blood transfusions | The need of blood transfusion during the followup | 6-18 weeks postpartum | |
Secondary | endomyometritis / PID | any events of endomyometritis / PID postpartum | 6-18 weeks postpartum | |
Secondary | Re-admissions to the hospital | cases that required re-admission to the hospital after discharge from tyhe postpartum ward. | up to 18 weeks |
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